Testing equipment with magnifying function

ABSTRACT

Embodiments disclose a device for testing biological specimen. The device includes a sample carrier and a detachable cover. The sample carrier includes a specimen holding area. The detachable cover is placed on top of the specimen holding area. The detachable cover includes a magnifying component configured to align with the specimen holding area. The focal length of the magnifying component is from 0.1 mm to 8.5 mm. The magnifying component has a linear magnification ratio of at least 1.

RELATED APPLICATION

This application is a continuation-in-part of U.S. Application No.15/152,470, filed May 11, 2016, the content of which is incorporatedherein by reference in its entirety.

FIELD OF THE INVENTION

The invention relates to equipment for testing biological specimen, andrelates particularly to testing equipment with a magnifying function oran analyte quantification function.

BACKGROUND OF THE INVENTION

Currently, testing of liquid contents, are typically consigned toprofessional testing authorities for performing testing using expensivemicroscope equipment with high magnification ratios. Since an individualdoes not have microscope equipment, the testing activity cannot beperformed by the individual.

However, in some testing categories nowadays testing is required to beperformed on a regular basis; therefore the need for frequent testingposes an excessive burden in terms of time and expense. For example, thecategory of long term testing includes semen testing for patients withinfertility issues. The semen testing is mainly directed to performingobservations on the number of sperms, their motility and morphology.

The semen testing method involves resting semen of a male subject at aroom temperature for a period of time, and taking a drop of the sampleand instilling the sample to a slide, and observing the sample under amicroscope. The observations not only include performing highmagnification observation of individual sperm to identify the externalappearance of individual sperm, but also include performing observationsof overall sperms in a large quantity, their motility, morphology andthe quantity per unit area. However, an individual cannot perform thesemen testing by himself because the industry have not yet developed atechnology that allows an individual to perform testing through a simpleaiding device.

SUMMARY OF THE INVENTION

The invention provides a testing equipment with magnifying function,which is significantly less expensive than conventional testingequipment, requires less labor for testing, and is easy to use. Thetechnology can be applied to semen testing, as well as other testingareas such as micro-organisms in water, water quality, blood, urine,body fluid, stool, and skin epidermis tissues/cells. The technologyprovides a simple testing product with significantly lower usage costthan convention techniques using laboratory microscope equipment.

Comparing to the conventional techniques, the testing equipment withmagnifying function disclosed herein provides a simple structure thatcan significantly lower the cost of specimen magnifying testingstructure, for tests such as sperm test, urinalysis or other body fluidanalysis. The technology disclosed herein can be used in a wide range ofapplications, through the design of the carrier having the specimenholding area, the magnifying part and the unique innovativeconfiguration. For example, the testing equipment with magnifyingfunction can be applied to inspect the counts, the motility and themorphology of sperm specimen.

The testing equipment with magnifying function of the invention issuitable for performing tests at home. The results of the test can beobtained instantly and the cost is low. For example, the testingequipment with magnifying function provides a way to assess malefertility at home for couples seeking pregnancy so that the couples canmake an informed decision whether medical intervention is needed.

The disclosed technology can be conveniently integrated with existingintelligent communications device (such as smart phone or tablet), andenables the use of existing intelligent communications device to capturemagnified testing images and perform subsequent operations such asstoring and transferring the images. The cost of the devices is low sothat the devices can be implemented as disposable devices or reusabledevices.

At least some embodiments of the present invention are directed to adevice (e.g., a test cartridge or a test strip) for testing biologicalspecimen. The device includes a sample carrier and a detachable cover.The sample carrier includes a specimen holding area. The detachablecover is placed on top of the specimen holding area. The detachablecover includes a magnifying component configured to align with thespecimen holding area. The focal length of the magnifying component isfrom 0.1 mm to 8.5 mm. The magnifying component has a linearmagnification ratio of at least 1.0.

At least some embodiments of the present invention are directed to asystem for testing biological specimen. The system includes the devicefor testing biological specimen mentioned above and a base component.The base component includes an insertion port for inserting the devicefor testing biological specimen into the base component. The basecomponent further includes a camera component for capturing the image ofthe specimen holding area, or a form-fitting frame for securing a mobiledevice that includes a camera component for capturing the image of thespecimen holding area. The base component can further include asupplemental lens placed below the camera component. A combination ofthe magnifying component and the supplemental lens can have an effectivelinear magnification ratio of at least 1.0.

At least some embodiments of the present invention are directed to amethod for testing sperms using the device for testing biologicalspecimen. The method includes steps of: obtaining the device for testingbiological specimen mentioned above, applying a sperm specimen to thespecimen holding area, recording a video or an image of the spermspecimen; determining the sperm count of the sperm specimen based on theat least one frame of the recorded video or the recorded image; anddetermining the sperm motility of the sperm specimen based on therecorded video or the recorded image.

At least some embodiments of the present invention are directed to asystem for testing biological specimen. The system includes a disposabledevice for testing biological specimen and a base component. Thedisposable device includes a sample carrier including a specimen holdingarea and a detachable cover placed on top of the specimen holding area.The base component includes an insertion port for inserting thedisposable device into the base component and a camera. The camera,which includes an image sensor and an optical lens module, captures oneor more image(s) of the specimen holding area.

Reference will now be made in detail to the present preferredembodiments of the invention, examples of which are illustrated in theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an exploded view of a testing equipment with magnifyingfunction according to an embodiment of the invention.

FIG. 1B is an assembled view of the testing equipment of FIG. 1A.

FIG. 2A is a cross-sectional view of the testing equipment of FIG. 1A.

FIG. 2B is a cross-sectional view of another embodiment of testingequipment.

FIG. 3 is a flow diagram of testing for a testing equipment according toan embodiment of the invention.

FIG. 4 is a cross-sectional view of a testing equipment with magnifyingfunction according to another embodiment of the invention.

FIG. 5 is a cross-sectional view of a testing equipment with magnifyingfunction according to another embodiment of the invention.

FIG. 6 is a schematic diagram of the testing equipment of FIG. 5 beingused.

FIG. 7 is a schematic diagram of a testing equipment with magnifyingfunction according to another embodiment of the invention.

FIG. 8 is a schematic diagram of a testing equipment with magnifyingfunction according to another embodiment of the invention.

FIG. 9 is a schematic diagram of a testing equipment with magnifyingfunction according to another embodiment of the invention.

FIG. 10 is a schematic diagram of a testing equipment with magnifyingfunction according to another embodiment of the invention.

FIGS. 11-13 are views of testing equipment with magnifying functionaccording to another three embodiments of the invention.

FIG. 14A is a schematic diagram of a test strip inserted into a meterdevice according to another embodiment of the invention.

FIG. 14B is a schematic diagram of components of a meter deviceaccording to another embodiment of the invention.

FIG. 15A illustrates a sample process of a semen test by device such asa meter device or an intelligent communications device.

FIG. 15B illustrates a sample step 1515 of the process illustrated inFIG. 15A.

FIG. 15C illustrates a sample step 1520 of the process illustrated inFIG. 15A.

FIG. 15D illustrates a sample step 1530 of the process illustrated inFIG. 15A.

FIG. 15E illustrates a sample step 1550 of the process illustrated inFIG. 15A.

FIG. 15F illustrates a sample step 1555 of the process illustrated inFIG. 15A.

FIG. 16 illustrates a sample process of determining sperm concentration.

FIG. 17 illustrates sample sperms and sample sperm trajectories.

FIG. 18 illustrates a sample process of determining sperm trajectoriesand motility.

FIG. 19 is a schematic diagram of a testing equipment including acollection bottle.

FIG. 20 is a schematic diagram of a testing equipment does not include acollection bottle.

FIGS. 21A and 21B are cross-sectional views of various embodiments of atesting equipment.

FIG. 22 is a schematic diagram of a testing equipment for a test stripdevice having two specimen holding area.

FIG. 23 is schematic diagram of components of a testing equipment havingan autofocus function.

FIG. 24 is schematic diagram of components of another testing equipmenthaving an autofocus function.

FIG. 25 is a schematic diagram of a testing equipment including a switchand a motor.

FIG. 26 is a schematic diagram of a testing equipment including aflexible element.

FIG. 27 is a flow chart of a process for analyzing semen specimen formale customers or patients.

FIG. 28 is a flow chart of a process for analyzing LH or HCG for femalecustomers or patients.

DESCRIPTION OF THE EMBODIMENTS

FIGS. 1A and 1B illustrate a testing equipment with magnifying functionaccording to an embodiment of the invention. Embodiments disclosedherein are used for illustration purpose and should not be construed asrequired limitation to the invention. The testing equipment withmagnifying function Al includes: a carrier 10 having a specimen holdingarea 11 formed on top of the carrier 10, a cover 20 stacked on top ofthe carrier 10, and at least one magnifying part 30 (also referred to asmagnifying component or magnifier) including a convex lens type surfaceformed on the cover 20.

The magnifying part 30 of the present embodiment includes a planarconvex lens as illustrated in FIG. 1A. However, other type of magnifyinglens, e.g., a dual-sided lenticular lens can be included as themagnifying part 30. The magnifying part 30 is disposed to be alignedwith and to cover the specimen holding area 11 of the carrier 10. Themagnifying part 30 may have various magnification ratios based ontesting requirements of various tests. For example, the tests caninclude semen test, urine test, synovial joint fluid test,dermatological test, water test, or other body fluid tests, etc.

A test using the testing equipment A1 with magnifying function of thepresent embodiment does not require additional magnifying lens orlaboratory microscopes, which are expensive and time-consuming tooperate. Furthermore, there is no needed to align the specimen holdingarea with the magnifying lens or laboratory microscopes.

As illustrated in FIG. 1A, the specimen holding area 11 of the carrier10 may be formed with a dented configuration. The dented configurationdesign provides a stable and large storage space containing a specimen40. The dented configuration allows the specimen to rest for a requiredperiod of time before performing the testing. For example, beforeperforming a motility testing on a semen specimen, it is necessary torest the semen specimen in a room temperature for a required period oftime before performing the motility testing.

The specimen 40 can be first instilled in the dented configuration,i.e., the specimen holding area 11 of the carrier 10 to rest for aperiod of time. As shown in FIG. 1B, a total area of the cover 20 can besmaller than a total area of the carrier 10. A specimen receiving port12 exposed outside the cover 20 is formed on one side of the specimenholding area 11. The specimen receiving port 12 can be designed to havea shape expanding outwards, which can help smoothly instilling thespecimen.

FIG. 2A shows an air channel 13 that extends beyond the other side ofthe cover 20 and is formed on the other side of the specimen holdingarea 11. The air channel 13 may prevent air filling the inside of thespecimen holding area 11, which prevent receiving of the specimen whenthe specimen is in a liquid status.

As shown in FIG. 2A, a lateral illumination device 50 can be disposed atone side of the carrier 20 of testing equipment A1. The lateralillumination device 50 can provide illumination for the specimen 40 inthe specimen holding area 11 and therefore improve resolution of thecaptured testing images of the specimen 40. In some embodiments, thespecimen holding area 11 can receive illustration from light source(s)on the top of or at the bottom of the testing equipment A1.

As illustrated in FIG. 1A, the magnifying part 30 and the cover 20 maybe integrally formed, i.e., the magnifying part 30 and the cover 20 canbe a single component. In other embodiments such as the embodimentillustrated in FIG. 2B, the detachable cover 20 and the magnifyingcomponent 30, which is disposed in the recess 21 of detachable cover 20,can each be separate components that are adapted to be integratedtogether. In other words, the same type of detachable cover 20 can beintegrated with different magnifying components 30 of variousmagnification ratios.

In some embodiments, the distance between the bottom of the detachablecover 20 and the specimen holding area 11 is from 0.005 mm to 10 mm. Insome embodiments, the distance between the bottom of the detachablecover 20 and the specimen holding area 11 is about 0.01 mm. The testingequipment can include one or more spacers (not shown) to ensure thedistance between the bottom of the detachable cover 20 and the specimenholding area 11. The spacer(s) can integrally formed with the detachablecover 20 or the specimen holding area 11 of the carrier 10.

In some embodiments, the strip including the carrier 10 and the cover 20is for sperm test. In some embodiments, the optimal angularmagnification ratio for determining sperm concentration and motility isabout 100 to 200. In some embodiments, the optimal angular magnificationratio for determining sperm morphology is about 200 to 300. The thinnerthe magnifying component, the higher the angular magnification ratio.

The focal length of the magnifying component can also relate to theangular magnification ratio. In some embodiments, a magnifying componentwith an angular magnification ratio of 100 has a focal length of 2.19mm. A magnifying component with an angular magnification ratio of 156has a focal length of 1.61 mm. A magnifying component with an angularmagnification ratio of 300 has a focal length of 0.73 mm. In someembodiments, the magnifying component has an angular magnification ratioof at least 30, preferably at least 50. In some embodiments, the focallength of the magnifying component is from 0.1 mm to 3 mm.

FIG. 3 illustrates a sample process for performing testing using thetesting equipment Al with magnifying function illustrated in FIG. 1B. Atstep S110, the specimen 40 to be tested is set in the specimen holdingarea 11. At step S110, the cover 20 is stacked on top the carrier 10,before setting the specimen 40 to be tested in the specimen holding area11 from the specimen receiving port 12. Alternatively, the specimen 40to be tested can be set in the specimen holding area 11 directly first,before the cover 20 is stacked on top the carrier 10. At step S120, thespecimen 40 is rested in the specimen holding area 11 selectively for aperiod of time according to testing requirements of the specimen 40. Atstep S130, an intelligent communication device (e.g., a mobile phone) isattached on the cover 20, and the camera of the mobile phone is alignedwith the magnifying part 30, to use the camera of the mobile phone tocapture a picture or video of the specimen through the magnifying part30. At step S140, an application (APP) running at the mobile phone orother analysis device may be used to perform analysis of the picture orvideo, for obtain testing results.

As illustrated in FIG. 4, a supporting side (such as a protruding part)14 may further be formed on a top of the cover 20 of a testing equipmentA2 at a border of the magnifying part 30. In some embodiments, theprotruding type support structure may be formed on top of the cover 20by the addition of the protruding part 14. When the user attempts to usean intelligent communications device 60 (e.g., a mobile device such as asmart phone or tablet) to capture the image or video of the specimen, aside of the intelligent communications device 60 having a camera 61 maybe secured to the protruding part 14 (along the direction shown by thearrow L1). Thus, the testing equipment A2 allows the user to use theintelligent communications device 60 for capturing the image or video ofthe specimen, and does not require an expensive testing apparatus forrecording the image or video. Furthermore, the height of the protrudingpart 14 can be pre-determined for a best observation distance based onspecification of the camera 61 and the testing equipment A2.

As shown in FIG. 5 and FIG. 6, a testing equipment A3 can include abarrel type base 70 (also referred to as base component). The barreltype base 70 includes a lower barrel base 71 and a upper barrel body 72that can be lifted or descended with respect to the lower barrel base71. The lower barrel base 71 has an insertion port 73 providing aninsert position for the cover 20 and the carrier 10 stacked together. Anupward lighting device 80 is disposed on a bottom part of the lowerbarrel base 71, to provide illumination to the combination of the cover20 and carrier 10 from the bottom. The upper barrel body 72 can include,e.g., at least one additional magnification lens 74 for furthermagnification.

The upper barrel body 72 can be attached to the lower barrel base 71using a screw thread mechanism such that the upper barrel body 72 thatcan be lifted or descended with respect to the lower barrel base 71 likea screw. In other words, the upper barrel body 72 can be rotated withrespect to the lower barrel base 71 along the arrow L2 directions suchthat the upper barrel body 72 moves up and down along the arrow L3directions with respect to the lower barrel base 71. By adjusting theheight of the upper barrel body 72 with respect to the lower barrel body71, the system adjusts the height of the magnification lens 74 (henchanging the magnification ratio) and the height of the camera 61.

An assembling frame 75 (also referred to as form-fitting frame) may bedisposed at an upper end of the upper barrel body 72. The assemblingframe 75 secures the intelligent communications device 60 at apre-determined position. The assembling frame 75 has a camera alignmenthole 76. The camera 61 of the intelligent communications device 60 canreceive light from the specimen through the camera alignment hole 76.

The camera 61 disposed on current intelligent communications device 60typically only have a digital zoom function. Generally an optical zoomlens is required for testing with a high accuracy. However, the userusing the testing equipment A3 does not need a camera 61 having anoptical zoom lens. The high adjustment function of the testing equipmentA3 provides a flexible solution for aligning the specimen, themagnifying lens, and the camera 61.

FIG. 6 shows the intelligent communications device 60 that has beenassembled and secured onto the assembling frame 75, which is disposed onthe upper barrel body 72. The cover 20 and the carrier 10 containing thespecimen 40 are inserted through the insertion port 73. The upwardlighting device 80 may provide illumination to and increase thebrightness of the specimen.

The upper barrel body 72 or the barrel type base 70 can rotated alongthe directions L2, to adjust the height of the magnification lens 74 andthe camera 61 upwards or downwards along the directions L3. The heightadjustment mechanism enables a function for adjusting the magnificationratio. The camera 61 may capture dynamic videos or static testing imagesof the specimen 40 after magnification. Furthermore, the intelligentcommunications device 60 can user its originally equipped functions tostore the captured videos or images, to transfer the testing images orvideos, and to conduct subsequent processing.

As shown in FIG. 7, a testing equipment A4 with magnifying functionincludes a plurality of magnifying parts 30, 30B, 30C with differentmagnification ratios disposed on the cover 20. The user may shift thecover 20 to align the specimen holding area 11 of the carrier 10 withany of the magnifying parts 30, 30B, 30C with different magnificationratios, in order to obtaining testing results with differentmagnification ratios. By this design, the testing equipment A4 withmagnifying function of a single module can be applied to satisfiesmagnification requirements of multiple testing protocols, without theneed of changing the magnifying part or the cover.

As shown in FIG. 8, a testing equipment A5 with magnifying functionincludes a flexible transparent film 15. The flexible transparent film15 is disposed between the carrier 10 and the magnifying part 30, andcovers the specimen holding area 11. The flexible transparent film 15covers the specimen 40 (in liquid state) such that the specimen 40 in aconfined space. Thus, outside influences due to air, dust and dirt areconfined to a minimum level. Furthermore, the testing equipment A5 mayadjust the focal length by the varying the thickness of the flexibletransparent film 15.

As shown in FIG. 9, the magnifying part 30 of a testing equipment A6with magnifying function is a planar convex lens, and a surface of themagnifying part 30 facing the carrier 10 is a protruding surface.Therefore, an upwardly concave type hollow part 21 is formed at thesurface of the magnifying part 30 facing the carrier 10. A focal lengthparameter H1 is defined by the thickness of the thickest part of themagnifying part 30 of the planar convex lens. As shown in FIG. 10, afocal length parameter H2 of a testing equipment A7 with magnifyingfunction is different than the focal length parameter H1 of FIG. 9.

The focal lengths H1 and H2 may be adjusted by changing thickness of thecover 20 or the size of the curvature of the magnifying part 30. Forexample, the focal length H2 shown in FIG. 10 is greater than the focallength H1 shown in FIG. 9, and is achieved by changing the size of thecurvature of the magnifying part 30. In this way, testing requirementsof various focal lengths may be satisfied by adopting differentmagnifying parts 30.

In some embodiments, the magnifying part 30 can be transparent and therest of the cover 20 can be opaque. In addition, the carrier 10 mayinclude the specimen holding area 11 which is transparent. The remainingof the carrier 10 can be opaque. When the testing operations areperformed on the testing equipment, the light can propagate through thethe specimen holding area 11, the magnifying part 30 such that chance oflight interference in other parts of the device is suppressed.

Referring to FIG. 11, in a testing equipment A8 with magnifyingfunction, the carrier 10 of the testing equipment A8 further includes alight beam auxiliary guiding structure 16 formed at the bottom surfaceof the carrier 10. The carrier 10 can be made of transparent ortranslucent material. The light beam auxiliary guiding structure 16 canbe opaque or include a granular structure, a rough pattern, an engravedpattern, or other suitable structure that scatters the light beamreaching the guiding structure 16. The light beam auxiliary guidingstructure 16 may provide a particular pattern for the entire surface ora partial surface of the cover and the carrier. The light beam auxiliaryguiding structure 16 may also be formed all around the side surfaces ofthe carrier 10.

When the cover 20 and the carrier 10 are stacked and are attached to theintelligent communications device 60 (as illustrated in FIG. 4 forexample), the magnifying part 30 is aligned with the camera 61 of theintelligent communications device 60. In addition, a fill light (notshown) can be disposed near the camera 61 on surfaces of the intelligentcommunications device 60. The light beam provided by the fill light maybe guided to the carrier 10 to illuminate the specimen holding area 11through the cover 20. At the same time, the light beam auxiliary guidingstructure 16 of the carrier 10 may cause the light beam provided by thefill light to scatter, further improving the brightness and illuminationuniformity of the specimen holding area 11.

By disposing the light beam auxiliary guiding structure 16, the testingequipment does not require an additional fill light source to illuminatethe carrier 10. Therefore, cover 20 includes a light-transmissivematerial so that the fill light from of the intelligent communicationsdevice 60 can reach the specimen through the cover 20. In somealternative embodiments, the device does not include a cover 20 and thefill light directly reach the carrier 10 without propagating through thecover 20.

The testing equipment A8 with magnifying function can include a non-slipfilm 92 and a pH test paper 94. The non-slip film 92 is attached on thesupporting side (such as the top side) of the cover 20, and is used tostably dispose the cover 20 to the camera 61 of the intelligentcommunications device 60, as shown in FIG. 4, such that the magnifyingpart 30 is aligned to the camera 61 of the intelligent communicationsdevice 60. Using the non-slip film 92, the positioning of theintelligent communications device 60 relative to the testing equipmentA8 is secured to a pre-determined configuration.

The non-slip film 92 can have an opening aligned to the magnifying part30, so that the non-slip film 92 does not block the light transmittedfrom the specimen through the magnifying part 30 to the camera 61. Thenon-slip film 92 can include a material of, for example, silicon. The pHtest paper 94 can be disposed on the specimen holding area 11 of thecarrier 10, to provide an indication of the pH value of the specimen.The pH test paper 94 may be replaced after the usage.

In addition, the magnifying part 30 and the cover 20 can adopt adetachable design. Thus, the user may select another magnifying part 31different from the magnifying part 30 to replace the original magnifyingpart 30 based on testing requirements. Various magnifying part can beassembled with the cover 20 are assembled to achieve differentmagnification ratios or other optical features.

Now referring to FIG. 12, a testing equipment A9 with magnifyingfunction can further include a specimen collection sheet 42 disposed inthe specimen holding area 11. The specimen collection sheet 42, forexample, has a specimen collection area 42A. The specimen collectionarea 42A can use adhesion or other methods to collect sperms,subcutaneous tissue/cells, parasite eggs and the like solid test bodies.In some embodiments, the specimen collection sheet 42 can serve as aspacer to maintain a distance between the cover 20 and the specimenholding area 11.

Next, referring to FIG. 13, a testing equipment A10 with magnifyingfunction can include an isolation component 98 disposed at the specimenholding area 11 between the carrier 10 and the cover 20. The isolationcomponent 98 can isolate the magnifying part 30 and the testing fluid inthe specimen holding area 11, and prevent the testing fluid fromcontaminating the magnifying part 30. In some embodiments, the isolationcomponent 98 can serve as a spacer to maintain a distance between thecover 20 and the specimen holding area 11. The isolation component 98can be integrated with the cover 20 as a single component.Alternatively, the isolation component 98 can be integrated with thecarrier 10 as a single component.

FIG. 14A is a schematic diagram of a test strip inserted into a meterdevice according to another embodiment of the invention. The test strip5 (also referred to test cartridge) includes a detachable cover 20 and acarrier 10. In other words, a combination of a detachable cover 20 and acarrier 10 (as illustrated in FIG. 1B for example) forms a test strip 5.The test strip 5 in in inserted into a meter device 70 (also referred toas base component) through an insertion port. The insertion port can be,e.g., a lateral or vertical insertion port. The meter device 70 caninclude, e.g., components for capturing images of specimen collected inthe test strip 5.

FIG. 14B is a schematic diagram of components of a meter deviceaccording to another embodiment of the invention. The meter device 70includes an insertion port 73 providing an insert position for the strip5. The strip 5 includes a carrier 10 and a detachable cover 20. Thedetachable cover includes a magnifying component 30. The meter device 70includes a camera 61 for capturing images or videos of the specimenholding area of the carrier 10. The camera 61 is aligned with themagnifying component 30. The meter device further includes a lightsource 80 for provide illumination for the specimen holding area fromthe bottom. In some embodiments, a light collimator (e.g., a collimatinglens or a light reflector; now shown) can be placed on top of the lightsource 80 for collimating the light beams. An annular diaphragm can befurther placed between the light source 80 and the light collimator sothat the light beams travelling through the light collimator form ahollow cone of light beams. The carrier 10 can include transparent ortranslucent materials for light prorogation.

In some embodiments, the meter device 70 can further include a phaseplate for shifting phases of light rays emitted from the specimenholding area. When light rays propagate through the specimen, the speedof light rays is increased or decreased. As a result, the light rayspropagating through the specimen are out of phase (by about 90 degrees)with the remaining light rays that do not propagate through thespecimen. The out-of-phase light rays interfere with each other andenhance the contrast between bright portions and dark portions of thespecimen image.

The phase plate can further shift the phases of the light rayspropagating through the specimen by about 90 degrees, in order tofurther enhance the contrast due to the interference of out-of-phaselight rays. As a result, the light rays propagating through the specimenare out of phase, by a total of about 180 degrees, with the remaininglight rays that do not propagate through the specimen. Such adestructive interference between the light rays enhances the contrast ofthe specimen image, by darkening the objects in the image and lighteningthe borders of the objects.

In some alternative embodiments, such a phase plate can be disposed ontop of the detachable cover 20 of the strip 5. In other words, the phaseplate can be part of the strip 5, instead of part of the meter device70.

FIG. 15 illustrates a sample process of a semen test by device such asthe meter device 70 or the intelligent communications device 60 asillustrated in FIGS. 5 and 14 respectively. At step 1505, the deviceobtains an image (frame) of the specimen. At step 1510, the devicedetermines the sperm concentration based on the image. By analyzing thecolor or the grayscale of the pH strip, at step 1515, the device canfurther determine the pH value of the specimen. For example, the devicecan include a processor to identify the color of a portion of an imagewhich is captured by camera, corresponding to the pH strip and todetermine a biochemical property (e.g., pH level) of a biologicalspecimen contained in the strip. In some other embodiments, the lightsource of the device can provide illumination with at least one color.For example, the light source can include light emitters with differentcolors (e.g., red, green and blue) to form light of various colors. Thecamera of the device can further capture at least one (or more) image ofthe sample being illuminated with light The processor can compare thecolors of a specific region (e.g., pH strip region) of the images todetermine a property of the biological specimen or quantification ofanalyte. In some embodiments, the processor only needs a color of thespecific region of one image to determine a property of the biologicalspecimen. For example, the device (e.g., a testing equipment) caninclude a color calibration module for calibrating the color of theimage. The processor then analyzes the calibrated image to determine theproperty of the biological specimen. Alternatively, the test strip caninclude a color calibration area that has a known color. The processorconducts a color calibration operation on the image based on the colorcalibration area, and then analyzes the calibrated image to determinethe property of the biological specimen or quantification of analyte. Insome embodiments, the reagent in the pH strip (or other types ofbiochemical test strips) reacts with the biological specimen, before thespecific region (e.g., pH strip region) of the images shows specificcolor(s). In some embodiments, the specific region for color detectiondoes necessarily need a magnification for the images captured by thecamera. Thus, at least in some embodiments, there is no magnifyingcomponent or supplement above a specific region of the strip for colordetection (e.g., pH strip region). For example, some types ofbiochemical test strips contain photochemical reagents. When aphotochemical reagent reacts with a specific analyte in the biologicalspecimen, the reaction causes a color change in the specimen holdingarea of the strip. The processor can analyze the image of the test strip(captured by the camera) to detect the color change and to quantify thespecific analyte in the biological specimen. Furthermore, the device candetermine the sperm morphology (1520), sperm capacity (1525) and spermtotal number (1530). At step 1540, the device obtains a series ofmultiple frames of the specimen. At steps 1545, 1550 and 1555, thedevice can determine the sperm motility parameters based on the spermtrajectory and determine the sperm motility.

FIG. 16 illustrates a sample process of determining sperm concentration.At 1605, a camera of the meter device 70 or the intelligentcommunications device 60 (“the device”), as illustrated in FIGS. 5 and14 respectively, captures a magnified image of the sperm specimen. Thecaptured image is an original image for the determining the spermconcentration. The device then converts the digital color image intodigital grayscale image, and further divides the digital grayscale imageinto multiple regions.

At step 1610, the device conduct an adaptive thresholding binarizationcalculation on each region, based on the mean value and standarddeviation of the grayscale values of that region. The goal of theadaptive thresholding binarization calculation is to identify objectsthat are candidates of sperms as foreground objects, and to identify therest of the region as background.

Foreground objects in the image after the binarization calculation maystill include impurities that are not actually sperms. Those impuritiesare either smaller than the sperms or larger than the sperms. The methodcan set an upper boundary value and a lower boundary value for the sizesof the sperms. At step 1615, the device conducts a denoising operationon the image by removing impurities that are larger than the upperboundary value or smaller than the lower boundary value for the sperms.After the denoising operation, the foreground objects in the imagerepresent sperms.

The method counts the number of sperms in the image based on the headportions of the sperms. At steps 1620 and 1625, the device conducts adistance transform operation to calculate a minimum distance between theforeground objects and the background, and also identify locations oflocal maximum values. Those locations are candidates of sperm headlocations.

At step 1630, the device conducts an ellipse fitting operation to eachsperm candidate object to reduce false positive candidates that do nothave ellipse shapes and therefore are not sperm heads. Then the devicecounts the total number of remaining positive candidates of sperms, andcalculates the concentration of the sperms based on the volumerepresented by the image. The volume can be, e.g., the area of thecaptured specimen holding area times the distance between the specimenholding area and the bottom of the cover.

In some embodiments, the device can use multiple images of the specimenand calculate concentration values based on the images respectively.Then the device calculates an average value of the concentration valuesto minimize the measurement error of the sperm concentration.

Using a series of images (e.g., video frames) of the specimen, thedevice can further determine the trajectories and motility of thesperms. For example, FIG. 17 illustrates sample sperms such as sperm1705 and sample sperm trajectories such as trajectory 1710 andtrajectory 1720.

FIG. 18 illustrates a sample process of determining sperm trajectoriesand motility. A camera of the meter device 70 or the intelligentcommunications device 60 (“the device”), as illustrated in FIGS. 5 and14 respectively, captures a series of images (e.g., video frames) of thesperm specimen. The device uses the captured series of images fordetermining parameters of sperm motility. In order to determine theparameters of sperm motility, the device needs to track the trajectoryof each sperm in the series of images.

The device converts the digital color images into digital grayscaleimages. The device first identifies the head positions of sperms in thefirst image of the series (e.g., using a method illustrated in FIG. 16).The identified head positions of the sperms in the first image are theinitial positions for the sperm trajectories to be tracked. In someembodiments, the device can use a two-dimensional Kalman filter toestimate the trajectory for the movement of the sperms.

In some embodiments, the two-dimensional Kalman Filter for trackingsperm s_(j) with measurement z_(j)(k) includes steps of:

-   1: Calculate the predicted state {circumflex over (x)}_(s) _(j)    (k|k−1) and error covariance matrix P_(s) _(j) (k|k−1):

{circumflex over (x)} _(s) _(j) (k|k−1)=F(k){circumflex over (x)} _(s)_(j) (k|−1|k−1)

P _(s) _(j() k|k−1)=F(k)P _(s) _(j) (k−1|k−1)F(k)^(T) +Q(k−1)

-   2: Using the predicted state {circumflex over (x)}_(s) _(j) (k|k−1),    the measurement z_(j)(k) and error covariance matrix P_(s) _(j)    (k|k−1), calculate the predicted measurement {circumflex over    (z)}_(s) _(j) (k−k−1), measurement residual v_(s) _(j) (k) and    residual covariance matrix S_(s) _(j) (k):

{circumflex over (z)} _(s) _(j) (k|k−1)=H(k){circumflex over (x)} _(s)_(j) (k|k−1)

v _(s) _(j) (k)=z _(j)(k)−{circumflex over (z)} _(s) _(j) (k|k−1)

S _(s) _(j) (k)=H(k)P _(s) _(j) (k|k−1)H(k)^(T) +N(k)

-   3: if v_(s) _(j) (k)^(T)S_(s) _(j) (k)⁻¹v_(s) _(j) (k)<γ and ∥v_(s)    _(j) (k)∥/T≦V_(max) then calculate the Kalman filter gain K_(s) _(j)    (k), updated state estimate {circumflex over (x)}_(s) _(j) (k|k),    and updated error covariance matrix P_(s) _(j(k|k):)

K _(s) _(j) (k)=P _(s) _(j) (k|k−1)H ^(T)(k)S _(s) _(j) (k)⁻¹

{circumflex over (x)} _(s) _(j) (k|k)={circumflex over (x)} _(s) _(j)(k|k−1)+K _(s) _(j) (k)v _(s) _(j) (k)

P _(s) _(j) (k|k)=P _(s) _(j) (k|k−1)−K _(s) _(j) (k)H(k)P _(s) _(j)(k|k−1)

(k|k−1) denotes a prediction of image k based on image k−1, ,x _(s) _(j)is the state of position and velocity of j-th sperm. P_(s) _(j) is thecovariance matrix of the estimation error, Q(k−1) is the process noisecovariance matrix, N(k) is the covariance matrix of white position noisevector, γ is the gate threshold and V_(max) is the maximum possiblesperm velocity.

When tracking multiple trajectories of multiple sperms, the method canuse joint probabilistic data association filter to decide the trajectorypaths. The joint probabilistic data association filter determines thefeasible joint association events between the detection targets andmeasurement targets. Feasible joint association events(A_(js)) is therelative probability values between the detection sperm s andmeasurement sperm j. Then the method conducts path allocation decisionsbased on optimal assignment method. A_(jt) is defined as:

$A_{js} = \{ \begin{matrix}{{- {\ln ( {\lambda^{- 1}{f_{s_{j}}\lbrack {z_{j}(k)} \rbrack}} )}},} & {{if}\mspace{14mu} {measurement}\mspace{14mu} {sperm}\mspace{14mu} j\mspace{14mu} {is}\mspace{14mu} {validated}\mspace{14mu} {by}\mspace{14mu} {track}\mspace{14mu} s} \\{\infty,} & {otherwise}\end{matrix} $

λ is the parameter, f_(s) _(j) [z_(j)(k)] is the Gaussian probabilitydensity function of the detection sperms.

Based on the series of frames within a time period, the methodidentifies the trajectory of each sperm, such as the trajectory 1805 asillustrated in FIG. 18. Then the method determines various parameters ofthe sperm mobility based on the trajectories. The parameters include,e.g., curvilinear velocity (VCL), straight-line velocity (VSL),linearity (LIN) and amplitude of lateral head displacement (ALH). Thecurvilinear velocity (VCL) 1810 is defined as a summation of movementdistances within a unit of time. The straight-line velocity (VSL) 1815is defined as a straight-line movement distance within a unit of time.The linearity (LIN) is defined as VSL divided by VCL. The amplitude oflateral head displacement (ALH) 1820 is defined as twice the amplitudeof the lateral displacement of the sperm head relative to the averagepath 1825.

In some embodiments, the curvilinear velocity (VCL) 1810 can be used todetermine the sperm motility. The method can set a velocity thresholdvalue. Any sperms having VCL higher than or equal to the velocitythreshold value are identified as active sperms. The rest of the sperms,which have VCL lower than the velocity threshold value, are identifiedas non-active sperms. The level of motility is the number of identifiedactive sperms divided by the total number of sperms recognized from theimages.

The method can further analyze the sperm morphology. A camera of themeter device 70 or the intelligent communications device 60 (“thedevice”) captures a magnified image of the sperm specimen. The capturedimage is an original image for the determining the sperm morphology.

The method detects the shapes of the sperm candidates based onsegmentation. The method uses the locations of heads of the sperms asthe initial points. Using a segmentation algorithm that relates to theshapes, the method divides the images of the sperms into head portions,neck portions and tail portions. For example, the method can divide thesperms using methods such as active contour model.

Based on the each portions, the method calculates parameters for thevarious portions (such as lengths and widths). A classifier (such assupport vector machine, neural network, convolutional neural network oradaboost) can be trained using training data set includes samples thatare labeled already. After the training, the parameters of the variousportions of the sperms can be fed to the classifier to determine whetherthe sperm has a proper morphology. In some embodiments, the classifiercan be used for other applications such as detecting properties of cellsand microbes.

FIG. 19 is a schematic diagram of a testing equipment including acollection bottle according to at least one embodiment of the invention.A test strip device 1905 can be inserted into the testing equipment 1900through an insertion port. The test strip device 1905 can include acollection bottle 1910 for collecting the specimen (e.g., spermspecimen) or include a slot for accommodating the collection bottle. Thetesting equipment 1900 can include a sensor (not shown) to detectwhether the collection bottle 1910 is inserted into the testingequipment 1900.

The testing equipment 1900 can have a timer mechanism for determining atime period during which the collection bottle 1910 is being insertedinto the testing equipment 1900. Once the collection bottle 1910containing the specimen is inserted, the testing equipment 1900 can waitfor a pre-determined time period (e.g., 30 minutes) for liquefaction ofthe specimen before prompting a user to transfer the specimen from thecollection bottle 1910 to the test strip device 1905. In someembodiments, the testing equipment 1900 can include a camera or a sensorto determine whether the specimen already liquefies.

Furthermore, the testing equipment can include a moving mechanism toapply a mechanical force to the collection bottle 1910 in order to mixspecimen in the collection bottle 1910. For example, the movingmechanism can, e.g., shake, vibrate, or rotate the collection bottle1910. In some other embodiments, the testing equipment can include a rodto be inserted into the collection bottle 1910 and to stir the specimenin the collection bottle 1910.

The testing equipment 1900 can include a screen 1920 for displayinformation. For example, the screen 1920 can show instructions or hintson how to operate the testing equipment 1900. The screen 1920 can alsoshow test results after the testing equipment 1900 conducts the test.

Similar to the testing equipment illustrated in FIGS. 14A and 14B, thetesting equipment 1900 can include a camera (not shown) for capturingimages or videos of the test strip device 1905. The testing equipment1900 can further include a processor (not shown) for processing theimages or videos for determining test results (e.g., through the processillustrated in FIG. 16).

In some embodiments, for example, the magnifying component 2110 is amagnifying lens. The magnifying power of the magnifying component 2110can be represented by either angular magnification ratio or linearmagnification ratio. An angular magnification ratio is a ratio betweenan angular size of an object as seen through an optical system and anangular size of the object as seen directly at a closest distance ofdistinct vision (i.e., 250 mm from a human eye). A linear magnificationratio is a ratio between a size of an image of an object being projectedon an image sensor and a size of the actual object.

For example, the magnifying lens can have a focal length of 6 mm, athickness of 1 mm and a diameter of 2 mm. Assuming 250 mm is the nearpoint distance of a human eye (i.e., the closest distance at which ahuman eye can focus), the angular magnification ratio is 250mm/6mm=41.7×. The distance between the magnifying component 2110 and thespecimen holding area 2115 can be, e.g., 9 mm. As a result, a linearmagnification ratio can approximate 2. In other words, a size of animage of an object on the image sensor caused by the magnifyingcomponent is 2 times a size of the actual object below the magnifyingcomponent.

In some embodiments, the magnifying component has a focal length of0.1-8.5 mm. In some embodiments, the linear magnification ratio of themagnifying component is at least 1. In some embodiments, the linearmagnification ratio of the magnifying component is from 0.5 to 10.0.

In some embodiments, a supplemental lens 2135 is placed below the cameramodule 2130 for further magnifying the image and decreasing the distancebetween the magnifying component 2110 and the specimen holding area2115. The effective linear magnification ratio of the whole opticalsystem can be, e.g., 3. In other words, the image of the object capturedby the camera module 2130 is has a size that is 3 times size of theactually object in the specimen holding area 2115. In some embodiments,the effective linear magnification ratio of the whole optical system ofthe testing equipment is from 1.0 to 100.0, preferably from 1.0 to 48.0.

In some embodiments, the image sensor of the camera module has a pixelsize of 1.4 μm. Typically a captured image of an object needs to take atleast 1 pixel in order to properly analyze the shape of the object. Thusthe size of the captured image of the object needs to be at least 1.4μm. If the linear magnification ratio of the testing equipment is 3, thetesting equipment can properly analyse the shape of objects having asize of at least 0.47 μm.

In some embodiments, the image sensor of the camera module has a pixelsize of 1.67 μm. Then the size of the captured image of the object needsto be at least 1.67 μm in order to properly analyze the shape of theobject. If the linear magnification ratio of the testing equipment is 3,the testing equipment can properly analyse the shape of objects having asize of at least 0.56 μm.

In some embodiments, for example, the length of the whole optical systemcan be, e.g., 24 mm. The distance between the bottom of the magnifyingcomponent and the top of the specimen holding area 2115 can be, e.g., 1mm. In some embodiments, length of the whole optical system of thetesting equipment is from 2 mm to 100 mm, preferably from 5 mm to 35 mm.

FIG. 20 is a schematic diagram of a testing equipment does not include acollection bottle, according to at least one embodiment of theinvention. Unlike the testing equipment 1900, the testing equipment 2000does not include a collection bottle or a slot for inserting acollection bottle. The specimen is directly applied to the test stripdevice 2005, by a user or an operator, without being collected in acollection bottle.

FIG. 21A is a cross-sectional view of an embodiment of the testingequipment 1900. The A-A section of the testing equipment 1900 shows acamera module 2130 on top of the test strip device 2105 for capturingimages or videos of the specimen holding area 2115 of the test stripdevice 2105. The test strip device 2105 includes a magnifying component2110 on top of the specimen holding area 2115. A light source 2140 belowthe test strip device 2105 provides illumination for the specimenholding area 2115. In some other embodiments, light source can be placedon top of the test strip device or laterally at a side of the test stripdevice. There can be multiple light sources or an array of light sourcesfor providing illumination on the test strip device. In someembodiments, different combinations of light sources can be switched,adjusted, or selected depending on the analyte types, such that theanalyte is illuminated by light with a proper color.

In some embodiments, the test strip device 2105 can include a test stripin or near the specimen holding area 2115. For example, the test stripcan be a pH test strip, an HCG (human chorionic gonadotropin) teststrip, an LH (luteinizing hormone) test strip or a fructose test strip.When the analyte of specimen in the specimen holding area interacts withthe chemical or biochemical agents in the test strip, some opticalproperties (e.g., color or light intensity) of the test strip canchange. The camera module 2130 can capture the color or intensity of thetest strip to determine a test result, such as a pH level, an HCG level,an LH level or fructose level. In some embodiments, the magnifyingcomponent 2110 above the test strip can be replaced with a transparentor translucent cover. Therefore, the testing equipment cansimultaneously conduct a qualification of the analyte in the specimenand conduct a further analysis of the specimen through one or moremagnified images of specimen.

FIG. 21B is a cross-sectional view of another embodiment of the testingequipment 1900. The A-A section of the testing equipment 1900 shows acamera module 2130, which includes a sensor and one or more lenses 2135(also referred to as supplemental lenses or optical lens module), on topof the test strip device 2105 for capturing images or videos of thespecimen holding area 2115 of the test strip device 2105. A light source2140 below the test strip device 2105 (or disposed at other places)provides illumination for the specimen holding area 2115. A magnifyingcomponent 2110 can be attached to the bottom of the lenses 2135, insteadof being on top of the specimen holding area 2115 as illustrated in FIG.21A. In some embodiments, the element 2110 can be a flatlight-transmissive cover having no magnification power, if the lenses2135 provide enough magnification power. In some other embodiments, thetesting equipment 1900 does not include the magnifying component 2110,if the lenses 2135 provide enough magnification power (e.g., if thelinear magnification ratio of the lenses 2135 is at least 1.0).

FIG. 22 is a schematic diagram of a testing equipment for a test stripdevice having two specimen holding areas. The test strip device 2205includes a specimen holding area 2215A and another specimen holding area2215B. A transparent or translucent cover 2210A is placed on top of thespecimen holding area 2215A. The light source 2240A providesillumination on the specimen holding area 2215A. The camera module 2230Acaptures images or videos of the specimen holding area 2215A.

A magnifying component 2210B is placed on top of the specimen holdingarea 2215B. The light source 2240B provides illumination on the specimenholding area 2215B. The camera module 2230B captures images or videos ofthe specimen holding area 2215B. In some embodiments, the specimenholding areas 2215A and 2215B can be included in a single test stripdevice 2205 as illustrated in FIG. 22. The test strip device 2205 can beinserted into the testing equipment through an insertion port.

In some other embodiments, two separate test strips devices can includethe specimen holding areas 2215A and 2215B respectively. Depending onthe need of the test, the location of the specimen holding areas 2215Aand 2215B in the test strips can be designed to be aligned with thecamera modules 2230A and 2230B. In some embodiments, the two test stripdevices are inserted into the testing equipment through two separateinsertion ports. The testing equipment can use a combination of thecamera module 2230A, light source 2240A and cover 2210A to quantify ananalyte or to determine a property of the specimen (e.g., pH level, LHlevel, HCG level, or fructose level). The testing equipment can furtheruse a combination of the camera module 2230B, light source 2240B andmagnifying component 2210B to analyse a magnified image of the specimento determine properties of the specimen (e.g., sperm quantity, spermmotility, sperm morphology, etc.). Depending on the requirements ofvarious types of biochemical tests, different combinations orconfigurations of light source(s) can be used to illuminate thebiochemical specimen. The locations of the magnifying components (e.g.,magnifying component of the camera module or magnifying component of thetest strips) and locations of the light source(s) can be adjusted orselected depending on the requirements of various types of analyteanalysis.

An optimal distance between the camera module and the magnifyingcomponent may have a low margin of error. For example, even a slightdeviation of 0.01 mm from the optimal distance can prevent the cameramodule to capture a clear image of the specimen holding area. In orderto fine tune the distance between the camera module and the magnifyingcomponent, the testing equipment can include an autofocus (AF) function.An autofocus function is function that automatically adjusts an opticalsystem (e.g., adjusts distances between components of the opticalsystem) so that the object being imaged (e.g., semen) is within thefocal plane of the optical system.

FIG. 23 is schematic diagram of components of a testing equipment havingan autofocus function. As shown in FIG. 23, the testing equipment canmove the camera module upward or downward along the Z-axis (e.g., by amotorized rail, an ultrasonic motor drive, or a stepping motor). Byadjusting the vertical position of the camera module, the testingequipment can adjust the distance between the camera module and themagnifying component.

FIG. 24 is schematic diagram of components of another testing equipmenthaving an autofocus function. As shown in FIG. 24, the testing equipmentcan move the test strip device upward or downward along the Z-axis. Byadjusting the vertical position of the test strip device, the testingequipment can adjust the distance between the camera module and themagnifying component.

During the autofocus operation as illustrated in FIG. 23 or 24, thecamera module and the supplemental lens are kept as a single module. Inother words, the distance between the camera module and the supplementallens remains unchanged during the autofocus operation as illustrated inFIG. 23 or 24.

FIG. 25 is a schematic diagram of a testing equipment including a switchand a motor. The B-B cross-section of the testing equipment 1900 in FIG.25 shows various components of the testing equipment. The testingequipment 1900 includes a switch 2550 to detect a collection bottle 2510being inserted into the testing equipment 1900. When the collectionbottle 2510 is inserted, the switch 2550 is activated. The testingequipment 1900 then is notified of the collection bottle 2510 throughthe switch 2550. Based on the time period for which the switch 2550 isbeing activated, the testing equipment can determine the time period forwhich the collection bottle 2510 stays inserted.

The testing equipment 1900 further includes a motor 2560 for shaking,vibrating, or rotating the collection bottle 2510 in order to mix thespecimen in the collection bottle 2510. The testing equipment 1900 caninclude a camera 2570 to determine whether the specimen alreadyliquefies based on captured images of the specimen in the collectionbottle 2510.

FIG. 26 is a schematic diagram of a testing equipment including aflexible element. The B-B cross-section of the testing equipment 1900 inFIG. 26 shows various components of the testing equipment. The testingequipment 1900 includes a moving element 2680 (e.g. elastic component)at the bottom of the slot for accommodating the collection bottle 2610in a moving manner. For example, the moving element 2680 can include aspring that can resume its normal shape spontaneously after contractionor distortion. When the collection bottle 2610 is inserted into theslot, the moving element 2680 is compressed. A light sensor 2690 (orother types of distance sensor) is responsible for detecting thedistance between the light sensor 2690 and the bottom of the collectionbottle 2610. Based on the distance between the light sensor 2690 and thebottom of the collection bottle 2610, the testing equipment 1900 candetermine the weight or the volume of the specimen contained in thecollection bottle 2610. For example, the distance between the lightsensor 2690 and the bottom of the collection bottle 2610 can beinversely proportional to the weight or the volume of the specimencontained in the collection bottle 2610.

In some other embodiments, the testing equipment 1900 can include asensor on top of the collection bottle 2610. The sensor can beresponsible for detecting a distance between the sensor and a top of thecollection bottle 2610. The weight or the volume of the specimencontained in the collection bottle 2610 can be determined based on thedistance because the volume or the weight can be, e.g., directlyproportional to the distance between the sensor and the top of thecollection bottle 2610. In turn, based on the weight or the volume ofthe specimen, the testing equipment 1900 can determine a time period forwaiting for the liquefaction of the specimen in the collection bottle2610. The testing equipment 1900 further includes a motor 2660 forshaking, vibrating, or rotating the collection bottle 2610 in order tomix the specimen in the collection bottle 2610

In some embodiments, the camera module of the testing equipment caninclude a light field camera (not shown) that captures intensities aswell as directions of the light rays. The light field camera can includean array of micro-lenses in front of an image sensor, or multi-cameraarrays to detect the directional information. Using the directionalinformation of the light rays, the camera module can capture clearimages at a wide range of the focal planes. Therefore, a testingequipment using a light field camera may not need an autofocus functionto fine adjust the distance between the camera module and the magnifyingcomponent.

FIG. 27 is a flow chart of a process for analyzing semen specimen formale customers or patients. The system for analyzing semen specimen caninclude a testing machine (e.g., testing equipment 1900), a mobiledevice and a cloud server. FIG. 28 is a flow chart of a process foranalyzing LH or HCG for female customers or patients. The system foranalyzing LH or HCG can include a testing machine (e.g., testingequipment 1900), a mobile device and a cloud server. The flow charts ofFIGS. 27 and 28 show steps performed by the testing machine, the mobiledevice and the cloud server and information being transferred among thetesting machine, the mobile device and the cloud server.

In some embodiments, a method for testing sperms comprises steps of:obtaining the device for testing biological specimen; applying a spermspecimen to the specimen holding area, recording a video or an image ofthe sperm specimen; determining the sperm count of the sperm specimenbased on the at least one frame of the recorded video or the recordedimage; and determining the sperm motility of the sperm specimen based onthe recorded video or the recorded image.

In a related embodiment, the method further comprises: waiting for apre-determined time period for liquefaction of the sperm specimen beforeapplying the sperm specimen to the specimen holding area.

In another related embodiment, the method further comprises: placing amobile device including a camera component on top of the device suchthat the camera component is aligned with the magnifying component andthe specimen holding area; and receiving by the mobile device lightsignal from the sperm specimen in the specimen holding area viamagnification by the magnifying component.

In yet another related embodiment, the method further comprises:illuminating the specimen holding area by a lateral illumination devicedisposed on a side of the carrier of the device or a verticalillumination device disposed on top of or below the carrier of thedevice.

In still another related embodiment, the method further comprises:guiding light beams from the lateral illumination device throughout thecarrier made of a transparent or translucent material; and reflectingthe light beams to the specimen holding area by a plurality of lightreflecting patterns included in the carrier.

In yet another related embodiment, the method further comprises:inserting the disposable testing device into a base, the base includinga camera component for recording the video of the sperm specimen, or aform-fitting frame for securing a mobile device that includes a cameracomponent for recording the video of the sperm specimen.

In still another related embodiment, the method further comprises:extracting at least one frame from the recorded video of the biologicalspecimen; identifying a plurality of sperms from the at least one frame;and calculating the sperm count based on a number of identified spermsand an area recorded by the at least one frame.

In yet another related embodiment, the method further comprises:analyzing shapes of the identified sperms; and determining a morphologylevel based on the shapes of the identified sperms.

In still another related embodiment, the method further comprises:extracting a series of video frames from the recorded video of the spermspecimen; identifying a plurality of sperms from the series of videoframes; identifying moving traces of the sperms based on the series ofvideo frames; determining moving speeds of the sperms based on themoving traces of the sperms and a time period captured by the series ofvideo frames; and calculating the sperm motility based on the movingspeeds of the sperms.

In yet another related embodiment, the method further comprises: furthermagnifying the video or the image of the sperm specimen through amagnifying lens.

In some embodiments, a method for testing sperms using the system fortesting biological specimen, comprises: inserting the device into thebase component; recording a video of the sperm specimen in the specimenholding area by the mobile device, the mobile device being secured inthe form-fitting frame of the base component; determining a sperm countof the sperm specimen based on the at least one frame of the recordedvideo; and determining a sperm motility of the sperm specimen based onthe recorded video.

In a related embodiment, the method further comprises: furthermagnifying the video of the sperm specimen through a magnifying lens.

In some embodiments, a system for testing biological specimen comprisesa disposable device for testing biological specimen and a basecomponent. The disposable device includes a sample carrier including aspecimen holding area, and a detachable cover placed on top of thespecimen holding area. The base component includes an insertion port forinserting the disposable device into the base component, and a cameracomponent for capturing the image of the specimen holding area, thecamera component including an image sensor and an optical lens module.In a related embodiment, the optical lens module can have a linearmagnification ratio of at least 0.1.

Although some of the embodiments disclosed herein apply the disclosedtechnology to sperm test, a person having ordinary skill in the artreadily appreciates that the disclosed technology can be applied to testvarious types of biological specimen, such as semen, urine, synovialjoint fluid, epidermis tissues or cells, water sample, etc.

It will be apparent to those skilled in the art that variousmodifications and variations can be made to the structure of the presentinvention without departing from the scope or spirit of the invention.In view of the foregoing, it is intended that the present inventioncover modifications and variations of this invention provided they fallwithin the scope of the following claims and their equivalents.

1. A device for testing biological specimen, comprising: a samplecarrier including a specimen holding area; a detachable cover placed ontop of the specimen holding area, the detachable cover including amagnifying component configured to align with the specimen holding area;wherein the focal length of the magnifying component is from 0.1 mm to8.5 mm, and the magnifying component has a linear magnification ratio ofat least 1.0.
 2. The device of claim 1, further comprising: a phaseplate for shifting phases of light rays from the specimen holding area.3. The device of claim 1, further comprising: a lateral light sourcedisposed on a side of the carrier for providing illumination to thespecimen holding area through the carrier, the carrier including atransparent or translucent material; or a vertical light source disposedon top of or below the carrier for providing illumination to thespecimen holding area.
 4. The device of claim 3, wherein the samplecarrier includes a plurality of light reflecting patterns, light beamsfrom the lateral light source are guided through the carrier and arereflected into the specimen holding area by the light reflectingpatterns.
 5. The device of claim 1, wherein a distance between thedetachable cover and the specimen holding area of the sample carrier isfrom 0.005 millimeter to 10 millimeters.
 6. The device of claim 1,wherein the specimen holding area contains a biological specimen.
 7. Asystem for testing biological specimen, comprising: a device of claim 1;a base component including: an insertion port for inserting the deviceof claim 1 into the base component; and a camera component for capturingthe image of the specimen holding area, or a form-fitting frame forsecuring a mobile device that includes a camera component for capturingthe image of the specimen holding area.
 8. The system of claim 7,wherein the base component includes a supplemental lens placed below thecamera component, a linear magnification ratio of an optical systemincluding the magnifying component and the supplemental lens is at least1.0.
 9. The system of claim 7, wherein the base component includes anautofocus mechanism to move the camera component to adjust a distancebetween the camera component and the magnifying component.
 10. Thesystem of claim 9, wherein the base component further includes asupplemental lens, and the autofocus mechanism moves the cameracomponent and the supplemental lens together during an autofocusoperation.
 11. The system of claim 7, wherein the base componentincludes an autofocus mechanism to move the device of claim 1 to adjusta distance between the camera component and the magnifying component.12. The system of claim 7, wherein the base component includes a slotfor accommodating a collection bottle for collecting the biologicalspecimen, a motor to shake or rotate the collection bottle for mixingthe biological specimen.
 13. The system of claim 7, wherein the basecomponent includes a slot for accommodating a collection bottle forcollecting the biological specimen, and a switch to detect thecollection bottle being inserted into the slot.
 14. The system of claim7, wherein the base component includes a distance sensor for detecting adistance between a bottom of the collection bottle and the sensor, andthe system determines a weight or a volume of the biological specimen inthe collection bottle based on the detected distance between the bottomof the collection bottle and the sensor.
 15. The system of claim 7,further comprising: a processor configured to determine a biochemicalproperty of a biological specimen contained in the specimen holdingarea, based on a color of a region within the image of the specimenholding area captured by the camera component.
 16. The system of claim7, further comprising: a light source configured to provide illuminationto the specimen holding area with at least one color; wherein the cameracomponent captures a first image and a second image of the specimen holdarea when the light source provide illumination with the at least onecolor; a processor configured to determine a property of a biologicalspecimen contained in the specimen holding area, based on comparisonbetween a first color of a region within the first image and a secondcolor of the region within the second image.
 17. The system of claim 7,further comprising: a screen configured to display instructions foroperating the system or test results for the biological specimen. 18.The system of claim 7, wherein the base component further includes: alight source for providing illumination to the specimen holding area; alight collimator for collimating light beams emitted from the lightsource to the specimen holding area; and an annular diaphragm betweenthe light source and the light collimator for forming a hollow cone oflight beams that travels through the light collimator and then reachesthe specimen holding area.
 19. The system of claim 7, wherein the basecomponent further includes: a phase plate between the specimen holdingarea and the camera component for phase-shifting light rays from thespecimen holding area.
 20. The system of claim 7, wherein the basecomponent further includes a magnifying lens for further magnifying animage of the specimen holding area; and wherein the base componentincludes an adjustment mechanism for adjusting a distance between themagnifying lens and the specimen holding area and therefor adjusting amagnification ratio for the image of the specimen holding area.
 21. Amethod for testing sperms, comprising the steps of: obtaining the deviceof claim 1; applying a sperm specimen to the specimen holding area;recording a video or an image of the sperm specimen; determining thesperm count of the sperm specimen based on the at least one frame of therecorded video or the recorded image; and determining the sperm motilityof the sperm specimen based on the recorded video or the recorded image.22. The method of claim 19, further comprising: extracting a series ofvideo frames from the recorded video of the sperm specimen; identifyinga plurality of sperms from the series of video frames; identifyingmoving traces of the sperms based on the series of video frames;determining moving speeds of the sperms based on the moving traces ofthe sperms and a time period captured by the series of video frames; andcalculating the sperm motility based on the moving speeds of the sperms.23. A system for testing biological specimen, comprising: a disposabledevice for testing biological specimen including: a sample carrierincluding a specimen holding area, and a detachable cover placed on topof the specimen holding area; and a base component including: aninsertion port for inserting the disposable device into the basecomponent, and a camera component for capturing the image of thespecimen holding area, the camera component including an image sensorand an optical lens module.
 24. The system of claim 23, wherein theoptical lens module has a linear magnification ratio of at least 0.1.